STANDARD PRODUCTS

SANITARY PIPELINE GASKETS:
1/ 2" THOUGH 12" BEVEL, CLAMP (TYPES I & II), SCHEDULE V, JP, APV, I & Q IN BUNA, EPDM, VITON®, SILICONE, TEFLON® & TEFSTEEL. ALL ELASTOMERS ARE 3-A APPROVED & FDA COMPLIANT. EPDM, VITON®, SILICONE, TEFLON® AND TEFSTEEL ARE ALL USP CLASS VI APPROVED.

SCREEN GASKETS:
AVAILABLE IN ALL ELASTOMERS AS WELL AS TEFLON® & TEFSTEEL. LARGEST SELECTION OF MICRON AND MESH SIZES IN THE INDUSTRY. PERFORATED DISC GASKETS ALSO AVAILABLE.

ORIFICE PLATES:
AVAILABLE IN ALL ELASTOMERS AS WELL AS TEFLON® & TEFSTEEL. DISCS ARE 316L STAINLESS; ELECTROPOLISH AVAILABLE.

0-RINGS:
AVAILABLE IN THE SAME COMPOUNDS AS OUR SANITARY GASKETS. ALL ARE FDA COMPLIANT AND WITH EXCEPTION OF BUNA CAN BE USP CLASS VI.

PLATE HEAT EXCHANGER GASKETS:
AVAILABLE FOR VIRTUALLY ANY MODEL IN ALL STANDARD MATERIALS. USP CLASS VI MATERIALS AVAILABLE.

FLANGE GASKETS:
150# & 300# FULL FACE AND RING GASKETS IN A VARIETY OF MATERIALS AND SIZES. ALSO AVAILABLE DM TEFSTEEL.

FITTINGS, TUBING & HOSE ASSEMBLIES:
COMPLETE LINE OF FITTINGS, BULK TUBING & CUSTOM MANUFACTURED SANITARY & INDUSTRIAL HOSE ASSEMBLIES.

PUMP & VALVE COMPONENTS:
COMPLETE LINE OF TRI-CLOVER CENTRIFUGAL PUMP WEAR PARTS AND SEAL KITS. MOLDED RUBBER VALVE STEMS FOR TRI-CLOVER DIVERT & SHUT-OFF VALVES. BALLS FOR TRI-CLOVER & C.B. CHECK VALVES. ALL STANDARD MATERIALS AND SIZES.

FILLER COMPONENTS:
LARGE SELECTION OF REPLACEMENT PARTS FOR CHERRY BURRELL/EVERGREEN FILLING MACHINES.

HOMOGENIZER COMPONENTS:
LARGE SELECTION OF REPLACEMENT PARTS FOR GAULIN HOMOGENIZERS.

PROPRIETARY & SPECIALTY PRODUCTS

DETECTABLE ELASTOMERS:
ANY MOLDED OR BONDED PRODUCT MANUFACTURED BY US CAN BE MADE DETECTABLE IN A CONDUCTIVE METAL DETECTOR.

TEFSTEEL COMPOUND:
THIS HOMOGENEOUS BLEND OF 50% 316L STAINLESS/50% PTFE DOES NOT COLD FLOW OR CREEP. NO I.D. INTRUSION. VIRTUALLY UNLIMITED SERVICE LIFE. BEST GASKET FOR SIP, ASEPTIC AND WFI APPLICATIONS. EXCELLENT CHEMICAL RESISTANCE & GOOD FOR CONTINUOUS SERVICE AT 500°F.

SMART GASKETS:
PERMITS ANY TRI-CLAMP UNION TO BE USED FOR TEMPERATURE PROBE, DRAWING SAMPLES, ADDING INGREDIENTS AND DOING SPORE STRIP TESTING.

PERFECT SURFACE GASKET SYSTEM:
TORQUE-RITE TORQUE NUT WITH MATED PERFECT SURFACE GASKET ELIMINATES I.D. GASKET INTRUSION.

TABBED & SELF DRAINING ORIFICE PLATES:
TAB ALLOWS EASY IDENTIFICATION OF ORIFICE LOCATION IN PROCESS LINE. SELF DRAINING FEATURE IS MOST DESIRABLE FOR HORIZONTAL LINE INSTALLATION.

MEDICAL GRADE GASKETS:
'/2" - 6" PLATINUM CURED SILICONE GASKETS (DOW Q7-4780) AVAILABLE FROM STOCK.

HPV GASKETS:
AVAILABLE 1" - 4" IN ANY ELASTOMER WITH PERFORATED METAL CORE. WILL WITHSTAND ABSOLUTE VACUUM AND ELEVATED OPERATING PRESSURES.

SUPERIOR GASKETS:
150# & 300# TEFLON® FULL SACE AND RING GASKETS WITH PERFORATED METAL CORE TO ELIMINATE COLD FLOW & CREEP.

TEFLON® & TEFSTEEL 150# FLANGE SCREEN GASKETS:
VARIETY OF STAINLESS MESH SIZES AVAILABLE.

LIQUAVAC BUNG TUBES:
MOST ECONOMICAL DEVICE AVAILABLE FOR COMPLETE REMOVAL OF LIQUIDS FROM STANDARD DRUMS.

BIOSEAL 2000:
TRULY PORTABLE TUBING SEAL/SAMPLE MACHINE.

This information has been carefully prepared to help in selecting the correct elastomer or perfluorocarbon utilized in high purity sanitary hygienic seals where critical pure water, process fluids (both ambient and hot), and SIP environments exist. The intention is to consider the different uses, applications and conditions to determine the most favorable gasket material for each application. The following criteria is used in determining correct sanitary gasket materials;

- U.S. Pharmacopoeia Class VI-XXII Certification

- Cytotoxicity Criteria

- CFR Title 21 Section 177.1550

- CFR Title 21 Section 177.2600

- Traceability: Lot and Batch

- Certification: Lot and Batch

- ASME-BPE Standards

- USDA Standards

- 3-A Sanitary Standards

- Current Good Manufacturing Practices (CGMP)

- Manufacturer data and specifications

- Consultation with various pharmaceutical users

The gasket materials considered are Tef-Steel® (Teflon/Stainless Steel), Teflon® (PTFE), Silicone (platinum), Viton®,    EPDM and Buna-N.

The 3 main goals are:

- To protect products from contamination, spalling, particulates and TOCs resulting from the use of improper sanitary gasket material.

- To protect facilities from unnecessary downtime associated with sanitary gasket failure and replacement from use of improper gasket material.

- To provide a standard of consistency of sanitary gaskets selection between multiple facilities.

Most decisions driving gasket type selection are based on chemistry, temperature, exposure limits, USP, FDA qualifications, and curing methods. The following briefly addresses each of these issues.

Exposure Limits

It is important to define the operating parameters of a new or existing processing sanitary system. The user specifications for exposure limits and reactivity to process fluids are compared with process operating parameters. All materials are acceptable for steam excluding Buna-N. All materials should meet process fluid reactivity parameters. Even though all compound exposure limits fall within operating parameters, the service life of some compounds will be different under certain conditions. This must be considered when selecting a compound.

FDA and USP Qualifications

CFR's define the criteria for extractibles and for compounds used in the manufacture of rubber and plastic articles. The two applicable categories are; rubber articles (Buna-N, EPDM, Viton®, Silicone) and perfluorocarbon resins (Teflon®).

USP defines the criteria for testing biological reactivity and the amount/type of extractables.
The gaskets in service must meet USP Class VI specifications, and be manufactured using the proper compounds as stated in the CFR, Title 21, Sections 177.1550 and 177.2600 respectively. Certificates are available from SPS verifying compliance with regulatory requirements, traceability lot and batch and certification lot and batch. Note: Not all sanitary gaskets meet these requirements.

Curing Methods

Curing agents have an affect on the amount and type of extractables a material will emit. Typically, the gasket group in service uses three methods; sulfur cured*, peroxide cured and platinum cured. When dealing with elastomers, peroxide cured is the most favorable method. When dealing with silicone, platinum cured is the most favorable. All gaskets shall be post cured. Using these methods minimize potential reactions with the respective process fluid applications and can uphold pure water and process fluid standards.

* Sulfur cured elastomers can significantly alter a process fluids integrity and negatively affect mammalian cell yields.

Note gasket identification for curing methods. For example, EPDM: one green dot (-) means sulfur cured and three green dots ( - - - ) means peroxide cured.

What Material(s) Can Be Used

By reviewing manufacturer data and compiling information regarding regulatory requirements, it appears that any of the aforementioned compounds are suitable for both utility and process equipment use. However, you must ensure that all gaskets and compounds meet the CFR and USP requirements, and have a certificate to verify compliance .

Click on illustration to enlarge image

Tel-Steel® is the material of choice if the application involves wide temperature variations, exception al chemical resistance (such as hydrocarbons, ethanol, ketones, etc.), outstanding service life.

Tenon® (PTFE) is the material of choice except if the application requires wide temperature variations (leakage will develop).

Silicone (platinum) is the third choice due to wide temperature compatibility range and resistance to chemicals.

Viton® is the fourth choice, however, service life must be considered and monitored

EPDM is the fifth choice in most applications due to temperature limitations.

Buna-N is the sixth choice in most applications due to temperature limitations and ** does not pass U.S. Pharmacopoeia Class VI-XXII Certification and Cylotoxicity.

This sheet indicates general preferences. Unique applications may require further considerations and analysis. When selecting gasket materials it is important to consider many factors: resistance to heat, resistance to SIP, resistance to chemicals like; hydrocarbons, ethanol, ketones, etc, tear strength, and flexibility. The service life of a material depends on t he application. Many of the materials are acceptable if the expected service life is very short in duration, however, in extended exposure sit­uations the material can degrade quickly rendering it ineffective or less desirable overall. This analysis was intended for sanitary gasket applications specif­ically. Sanitary gasket applications are inherently static and can be dynamic. When different perform­ance attributes are a consideration in dynamic appli­cations, Tef-Steel may be the material of choice.